Re: Safe drugs for children (clinical trials)

[Guest guest]

Hello Dr Deepali, and all

You have nicely quoted the hurdles in paediatric clinical trials. Interest of pharma companies (cost-benefit issue) in development of medicines specific for this group limits our knowledge about safety, efficacy, and toterability of medicines.

Dose range of medicine, specific indication is not known many times. If we use medicines which are indicated in children to treat disease in them it is termed as "Off label" use of medicine. This might lead to suboptimal dosing (evolution of medicine resistant micro organisms) by over conscious prescriber or exposure to increased dose of medicine having ADR in children.

In this regard pharmacokinetic studies are important.

Recruitment of patients, adequacy of sample size, consent of the participant (minor group not eligible to give consent), comfort of paediatric participants, minimizing risk faced by children in trials, and reimbursement/compensation for participants are some of the issues salient to paediatric clinical trials.

Elaboration of these points with further extension of list and solution for these problems needs discussion and contribution from other end.

Regards,

Dr Smita,GMC, Nagpur. > > > >> > > > > > > > Hello Smita and Netrumians,> > > > > > > > > > > > > > > > First of all congratulations for getting> > > opportunity to moderate > > > once> > > > again.> > > > > > > > A sick child is the source of great anxiety to> > > both doctors and > > > carers,> > > > can be a huge diagnostic challenge.> > > > > > > > Indian markets are flooded with. thousands of> > > formulations of > > > vitamins,> > > > tonics and multi-drug combinations that are unique> > > to the Indian > > > market> > > > are manufactured and marketed here. A visit to the> > > pediatrician > > > has come> > > > to necessarily mean a prescription comprising of a> > > shot gun > > > combination> > > > of antibiotics & #8211; one and more, an anti> > pyretic or> > > frequently an> > > > unnecessary combination of two, a multivitamin> > > tonic and a > > > combination> > > > cough syrup. Intravenous rehydration and> > > parenteral medication are > > > used> > > > far more frequently than rationally warranted.> > > Widespread > > > experience> > > > clearly shows that the vast majority of doctors'> > > prescriptions for> > > > children are quite irrational.> > > > > > > > Analyzing some of the commonest prescribed groups> > > of drugsà> > > > > > > > Tonics And Cough Syrupsà> > > > > > > > According to Health Action International "More> > > than four out of> > > > every five vitamin preparations cannot be> > > recommended; nearly > > > three out> > > > of every five is indicated for unproven> > > indications; more than two > > > out> > > > of every five contain non-essential or ineffective> > > ingredients; > > > more> > > > than one out of every two is irrationally> > > formulated; and nearly > > > one out> > > > of every two contains excessive dosage."> > > > > > > > Over 80 per cent of cough and cold remedies on the> > > market are> > > > irrational, most with ineffective and some with> > > dangerous > > > ingredients.> > > > > > > > Vaccinesà> > > > > > > > There is growing trend towards prescribing> > > optional vaccines and> > > > vaccines like> > > > > > > > anti pneumococcal vaccine and influenza vaccine> > > are being used > > > routinely> > > > by some, if not many doctors though this has no> > > current > > > justification> > > > Vaccinations have become the major source of > > > bread and butter of > > > the> > > > pediatrician.> > > > > > > > Analgesicsà> > > > > > > > The medical community's response to drugs like> > > nimuselide, a drug> > > > aggressively promoted in India for bringing down> > > fever in > > > children, is> > > > also an eye opener. The justice is still out in> > > India as to its > > > safety> > > > in children, with many professional organisations> > > declaring it > > > safe and> > > > others claiming to have seen children die as a> > > result of liver > > > failure> > > > from its use. so why to take risk when there are> > > excellent time > > > tested> > > > safe analgesia is available for children. other> > > countries, issued a> > > > precautionary advice on the marketing of the drug> > > following some > > > serious> > > > complications of the liver, especially in> > > children. Owing to the > > > death> > > > of a patient due to liver failure and following> > > reports of other > > > adverse> > > > drug reaction, banned in many countries It is> > > interesting to note > > > that.> > > > Bangladesh was the last country to ban the drug.> > > However, > > > paediatricians> > > > in India continue blissfully to prescribe the drug> > > and drug > > > companies> > > > continue to prevail upon them and make it> > > lucrative for the > > > practice to> > > > continue.> > > > > > > > Sedativesà> > > > > > > > Prescribing any kind of sedative just because to> > > diminish crying in> > > > infants in highly objectionable. Many pediatrician> > > giving H1> > > > antihistaminic hydroxyzine only to calm children,> > > which should not > > > be> > > > done owing to its other hazardous side effects.> > > > > > > > > > > > > > > > Regards,> > > > > > > > Dr Deepali> > > > > > > > GMC> > > > > > > > Nagpur> > > > > === message truncated ===> > > > > > > > Chat on a cool, new interface. No download required. Go to http://in.messenger./webmessengerpromo.php> >> > > > > > > ---------------------------------> Share files, take polls, and discuss your passions - all under one roof. Click here.>

[Guest guest]

Hello,

Thawani sir has rightly raised practical problem that though consent is obtained from guardians, it is the child who will decide whether to co-operate or not. They are king of their world. So it is our or investigators skill how to handle these princes.

Practical considerations to ensure that participants' experiences in clinical studies are positive and to minimize discomfort and distress include the following:

Ø Personnel knowledgeable and skilled in dealing with the pediatric population and its age-appropriate needs, including skill in performing pediatric procedures

Ø A physical setting with furniture, play equipment, activities, and food appropriate for age

Ø The conduct of studies in a familiar environment such as the hospital or clinic where participants normally receive their care

Ø Approaches to minimize discomfort of procedures, such as:

Topical anesthesia to place IV catheters

Indwelling catheters rather than repeated venipunctures for blood sampling

Collection of some protocol-specified blood samples when routine clinical samples are obtained

Also population kinetic/dynamic approach, in silico analysis can be used to make the subjects comfortable.

I again insist please come up NetRUMians with your views. What all measures can be taken in addition to this?

Regards,

Dr Smita,

GMC, Nagpur.

> > > > > >> > > > > >> > > > > > Hello Smita and Netrumians,> > > > > >> > > > > >> > > > > >> > > > > > First of all congratulations for getting> > > > > opportunity to moderate> > > > > once> > > > > > again.> > > > > >> > > > > > A sick child is the source of great anxiety to> > > > > both doctors and> > > > > carers,> > > > > > can be a huge diagnostic challenge.> > > > > >> > > > > > Indian markets are flooded with. thousands of> > > > > formulations of> > > > > vitamins,> > > > > > tonics and multi-drug combinations that are unique> > > > > to the Indian> > > > > market> > > > > > are manufactured and marketed here. A visit to the> > > > > pediatrician> > > > > has come> > > > > > to necessarily mean a prescription comprising of a> > > > > shot gun> > > > > combination> > > > > > of antibiotics & #8211; one and more, an anti> > > > pyretic or> > > > > frequently an> > > > > > unnecessary combination of two, a multivitamin> > > > > tonic and a> > > > > combination> > > > > > cough syrup. Intravenous rehydration and> > > > > parenteral medication are> > > > > used> > > > > > far more frequently than rationally warranted.> > > > > Widespread> > > > > experience> > > > > > clearly shows that the vast majority of doctors'> > > > > prescriptions for> > > > > > children are quite irrational.> > > > > >> > > > > > Analyzing some of the commonest prescribed groups> > > > > of drugsà> > > > > >> > > > > > Tonics And Cough Syrupsà> > > > > >> > > > > > According to Health Action International "More> > > > > than four out of> > > > > > every five vitamin preparations cannot be> > > > > recommended; nearly> > > > > three out> > > > > > of every five is indicated for unproven> > > > > indications; more than two> > > > > out> > > > > > of every five contain non-essential or ineffective> > > > > ingredients;> > > > > more> > > > > > than one out of every two is irrationally> > > > > formulated; and nearly> > > > > one out> > > > > > of every two contains excessive dosage."> > > > > >> > > > > > Over 80 per cent of cough and cold remedies on the> > > > > market are> > > > > > irrational, most with ineffective and some with> > > > > dangerous> > > > > ingredients.> > > > > >> > > > > > Vaccinesà> > > > > >> > > > > > There is growing trend towards prescribing> > > > > optional vaccines and> > > > > > vaccines like> > > > > >> > > > > > anti pneumococcal vaccine and influenza vaccine> > > > > are being used> > > > > routinely> > > > > > by some, if not many doctors though this has no> > > > > current> > > > > justification> > > > > > Vaccinations have become the major source of> > > > > bread and butter of> > > > > the> > > > > > pediatrician.> > > > > >> > > > > > Analgesicsà> > > > > >> > > > > > The medical community's response to drugs like> > > > > nimuselide, a drug> > > > > > aggressively promoted in India for bringing down> > > > > fever in> > > > > children, is> > > > > > also an eye opener. The justice is still out in> > > > > India as to its> > > > > safety> > > > > > in children, with many professional organisations> > > > > declaring it> > > > > safe and> > > > > > others claiming to have seen children die as a> > > > > result of liver> > > > > failure> > > > > > from its use. so why to take risk when there are> > > > > excellent time> > > > > tested> > > > > > safe analgesia is available for children. other> > > > > countries, issued a> > > > > > precautionary advice on the marketing of the drug> > > > > following some> > > > > serious> > > > > > complications of the liver, especially in> > > > > children. Owing to the> > > > > death> > > > > > of a patient due to liver failure and following> > > > > reports of other> > > > > adverse> > > > > > drug reaction, banned in many countries It is> > > > > interesting to note> > > > > that.> > > > > > Bangladesh was the last country to ban the drug.> > > > > However,> > > > > paediatricians> > > > > > in India continue blissfully to prescribe the drug> > > > > and drug> > > > > companies> > > > > > continue to prevail upon them and make it> > > > > lucrative for the> > > > > practice to> > > > > > continue.> > > > > >> > > > > > Sedativesà> > > > > >> > > > > > Prescribing any kind of sedative just because to> > > > > diminish crying in> > > > > > infants in highly objectionable. Many pediatrician> > > > > giving H1> > > > > > antihistaminic hydroxyzine only to calm children,> > > > > which should not> > > > > be> > > > > > done owing to its other hazardous side effects.> > > > > >> > > > > >> > > > > >> > > > > > Regards,> > > > > >> > > > > > Dr Deepali> > > > > >> > > > > > GMC> > > > > >> > > > > > Nagpur> > > > >> > > > === message truncated ===> > > >> > > >> > > >> > > > Chat on a cool, new interface. No download required. Go to> > http://in.messenger./webmessengerpromo.php> > > >> > >> > >> > >> > >> > >> > >> > > ---------------------------------> > > Share files, take polls, and discuss your passions - all under > one> > roof. Click here.> > >> >>

[Guest guest]

Hello Smita,

Uptill now we have discussed about first three phases of clinical

trial about safety in pediatric pharmacotherapy, but the fourth

phase and also Pharmacovigilane is still remaining.

I think it to be of more importance than the other three phases, as

it is the outcome of clinical reaserch..

Regards

Dr. Narendra Bachewar

GMC, Nagpur

> > > > > > >

> > > > > > >

> > > > > > > Hello Smita and Netrumians,

> > > > > > >

> > > > > > >

> > > > > > >

> > > > > > > First of all congratulations for getting

> > > > > > opportunity to moderate

> > > > > > once

> > > > > > > again.

> > > > > > >

> > > > > > > A sick child is the source of great anxiety to

> > > > > > both doctors and

> > > > > > carers,

> > > > > > > can be a huge diagnostic challenge.

> > > > > > >

> > > > > > > Indian markets are flooded with. thousands of

> > > > > > formulations of

> > > > > > vitamins,

> > > > > > > tonics and multi-drug combinations that are unique

> > > > > > to the Indian

> > > > > > market

> > > > > > > are manufactured and marketed here. A visit to the

> > > > > > pediatrician

> > > > > > has come

> > > > > > > to necessarily mean a prescription comprising of a

> > > > > > shot gun

> > > > > > combination

> > > > > > > of antibiotics & #8211; one and more, an anti

> > > > > pyretic or

> > > > > > frequently an

> > > > > > > unnecessary combination of two, a multivitamin

> > > > > > tonic and a

> > > > > > combination

> > > > > > > cough syrup. Intravenous rehydration and

> > > > > > parenteral medication are

> > > > > > used

> > > > > > > far more frequently than rationally warranted.

> > > > > > Widespread

> > > > > > experience

> > > > > > > clearly shows that the vast majority of doctors'

> > > > > > prescriptions for

> > > > > > > children are quite irrational.

> > > > > > >

> > > > > > > Analyzing some of the commonest prescribed groups

> > > > > > of drugsà

> > > > > > >

> > > > > > > Tonics And Cough Syrupsà

> > > > > > >

> > > > > > > According to Health Action International " More

> > > > > > than four out of

> > > > > > > every five vitamin preparations cannot be

> > > > > > recommended; nearly

> > > > > > three out

> > > > > > > of every five is indicated for unproven

> > > > > > indications; more than two

> > > > > > out

> > > > > > > of every five contain non-essential or ineffective

> > > > > > ingredients;

> > > > > > more

> > > > > > > than one out of every two is irrationally

> > > > > > formulated; and nearly

> > > > > > one out

> > > > > > > of every two contains excessive dosage. "

> > > > > > >

> > > > > > > Over 80 per cent of cough and cold remedies on the

> > > > > > market are

> > > > > > > irrational, most with ineffective and some with

> > > > > > dangerous

> > > > > > ingredients.

> > > > > > >

> > > > > > > Vaccinesà

> > > > > > >

> > > > > > > There is growing trend towards prescribing

> > > > > > optional vaccines and

> > > > > > > vaccines like

> > > > > > >

> > > > > > > anti pneumococcal vaccine and influenza vaccine

> > > > > > are being used

> > > > > > routinely

> > > > > > > by some, if not many doctors though this has no

> > > > > > current

> > > > > > justification

> > > > > > > Vaccinations have become the major source of

> > > > > > bread and butter of

> > > > > > the

> > > > > > > pediatrician.

> > > > > > >

> > > > > > > Analgesicsà

> > > > > > >

> > > > > > > The medical community's response to drugs like

> > > > > > nimuselide, a drug

> > > > > > > aggressively promoted in India for bringing down

> > > > > > fever in

> > > > > > children, is

> > > > > > > also an eye opener. The justice is still out in

> > > > > > India as to its

> > > > > > safety

> > > > > > > in children, with many professional organisations

> > > > > > declaring it

> > > > > > safe and

> > > > > > > others claiming to have seen children die as a

> > > > > > result of liver

> > > > > > failure

> > > > > > > from its use. so why to take risk when there are

> > > > > > excellent time

> > > > > > tested

> > > > > > > safe analgesia is available for children. other

> > > > > > countries, issued a

> > > > > > > precautionary advice on the marketing of the drug

> > > > > > following some

> > > > > > serious

> > > > > > > complications of the liver, especially in

> > > > > > children. Owing to the

> > > > > > death

> > > > > > > of a patient due to liver failure and following

> > > > > > reports of other

> > > > > > adverse

> > > > > > > drug reaction, banned in many countries It is

> > > > > > interesting to note

> > > > > > that.

> > > > > > > Bangladesh was the last country to ban the drug.

> > > > > > However,

> > > > > > paediatricians

> > > > > > > in India continue blissfully to prescribe the drug

> > > > > > and drug

> > > > > > companies

> > > > > > > continue to prevail upon them and make it

> > > > > > lucrative for the

> > > > > > practice to

> > > > > > > continue.

> > > > > > >

> > > > > > > Sedativesà

> > > > > > >

> > > > > > > Prescribing any kind of sedative just because to

> > > > > > diminish crying in

> > > > > > > infants in highly objectionable. Many pediatrician

> > > > > > giving H1

> > > > > > > antihistaminic hydroxyzine only to calm children,

> > > > > > which should not

> > > > > > be

> > > > > > > done owing to its other hazardous side effects.

> > > > > > >

> > > > > > >

> > > > > > >

> > > > > > > Regards,

> > > > > > >

> > > > > > > Dr Deepali

> > > > > > >

> > > > > > > GMC

> > > > > > >

> > > > > > > Nagpur

> > > > > >

> > > > > === message truncated ===

> > > > >

> > > > >

> > > > >

> > > > > Chat on a cool, new interface. No download required. Go to

> > > http://in.messenger./webmessengerpromo.php

> > > > >

> > > >

> > > >

> > > >

> > > >

> > > >

> > > >

> > > > ---------------------------------

> > > > Share files, take polls, and discuss your passions - all

under

> > one

> > > roof. Click here.

> > > >

> > >

> >

>

[Guest guest]

Hello Dr Narendra,

It is appreciable question asked by you leading the discussion ahead in more and more safe direction.

The conduct of pharmacovigilance for medicines for paediatric use requires special attention as:

· Childhood diseases may be qualitatively and quantitatively different from their adult equivalents affecting either the benefit or the risk of therapies (or both).

· Chronic conditions may require chronic treatment and the susceptibility to ADRs may change throughout the patient's life-time according to age and the stage of growth and development.

· Growth and development during childhood is a continuous interrelated processes and interaction with these may result in ADRs not seen in the adult population, irrespective of the duration of treatment.

· Associated rapid changes in body mass, morphology and composition may present additional challenges in identifying and selecting the optimum dosing regimen.

Also lack of database in this regards make the problem worse. We will have a look over it in next post....

Regards,

Dr Smita,

GMC, Nagpur.> > > > > > > >> > > > > > > >> > > > > > > > Hello Smita and Netrumians,> > > > > > > >> > > > > > > >> > > > > > > >> > > > > > > > First of all congratulations for getting> > > > > > > opportunity to moderate> > > > > > > once> > > > > > > > again.> > > > > > > >> > > > > > > > A sick child is the source of great anxiety to> > > > > > > both doctors and> > > > > > > carers,> > > > > > > > can be a huge diagnostic challenge.> > > > > > > >> > > > > > > > Indian markets are flooded with. thousands of> > > > > > > formulations of> > > > > > > vitamins,> > > > > > > > tonics and multi-drug combinations that are unique> > > > > > > to the Indian> > > > > > > market> > > > > > > > are manufactured and marketed here. A visit to the> > > > > > > pediatrician> > > > > > > has come> > > > > > > > to necessarily mean a prescription comprising of a> > > > > > > shot gun> > > > > > > combination> > > > > > > > of antibiotics & #8211; one and more, an anti> > > > > > pyretic or> > > > > > > frequently an> > > > > > > > unnecessary combination of two, a multivitamin> > > > > > > tonic and a> > > > > > > combination> > > > > > > > cough syrup. Intravenous rehydration and> > > > > > > parenteral medication are> > > > > > > used> > > > > > > > far more frequently than rationally warranted.> > > > > > > Widespread> > > > > > > experience> > > > > > > > clearly shows that the vast majority of doctors'> > > > > > > prescriptions for> > > > > > > > children are quite irrational.> > > > > > > >> > > > > > > > Analyzing some of the commonest prescribed groups> > > > > > > of drugsà> > > > > > > >> > > > > > > > Tonics And Cough Syrupsà> > > > > > > >> > > > > > > > According to Health Action International "More> > > > > > > than four out of> > > > > > > > every five vitamin preparations cannot be> > > > > > > recommended; nearly> > > > > > > three out> > > > > > > > of every five is indicated for unproven> > > > > > > indications; more than two> > > > > > > out> > > > > > > > of every five contain non-essential or ineffective> > > > > > > ingredients;> > > > > > > more> > > > > > > > than one out of every two is irrationally> > > > > > > formulated; and nearly> > > > > > > one out> > > > > > > > of every two contains excessive dosage."> > > > > > > >> > > > > > > > Over 80 per cent of cough and cold remedies on the> > > > > > > market are> > > > > > > > irrational, most with ineffective and some with> > > > > > > dangerous> > > > > > > ingredients.> > > > > > > >> > > > > > > > Vaccinesà> > > > > > > >> > > > > > > > There is growing trend towards prescribing> > > > > > > optional vaccines and> > > > > > > > vaccines like> > > > > > > >> > > > > > > > anti pneumococcal vaccine and influenza vaccine> > > > > > > are being used> > > > > > > routinely> > > > > > > > by some, if not many doctors though this has no> > > > > > > current> > > > > > > justification> > > > > > > > Vaccinations have become the major source of> > > > > > > bread and butter of> > > > > > > the> > > > > > > > pediatrician.> > > > > > > >> > > > > > > > Analgesicsà> > > > > > > >> > > > > > > > The medical community's response to drugs like> > > > > > > nimuselide, a drug> > > > > > > > aggressively promoted in India for bringing down> > > > > > > fever in> > > > > > > children, is> > > > > > > > also an eye opener. The justice is still out in> > > > > > > India as to its> > > > > > > safety> > > > > > > > in children, with many professional organisations> > > > > > > declaring it> > > > > > > safe and> > > > > > > > others claiming to have seen children die as a> > > > > > > result of liver> > > > > > > failure> > > > > > > > from its use. so why to take risk when there are> > > > > > > excellent time> > > > > > > tested> > > > > > > > safe analgesia is available for children. other> > > > > > > countries, issued a> > > > > > > > precautionary advice on the marketing of the drug> > > > > > > following some> > > > > > > serious> > > > > > > > complications of the liver, especially in> > > > > > > children. Owing to the> > > > > > > death> > > > > > > > of a patient due to liver failure and following> > > > > > > reports of other> > > > > > > adverse> > > > > > > > drug reaction, banned in many countries It is> > > > > > > interesting to note> > > > > > > that.> > > > > > > > Bangladesh was the last country to ban the drug.> > > > > > > However,> > > > > > > paediatricians> > > > > > > > in India continue blissfully to prescribe the drug> > > > > > > and drug> > > > > > > companies> > > > > > > > continue to prevail upon them and make it> > > > > > > lucrative for the> > > > > > > practice to> > > > > > > > continue.> > > > > > > >> > > > > > > > Sedativesà> > > > > > > >> > > > > > > > Prescribing any kind of sedative just because to> > > > > > > diminish crying in> > > > > > > > infants in highly objectionable. Many pediatrician> > > > > > > giving H1> > > > > > > > antihistaminic hydroxyzine only to calm children,> > > > > > > which should not> > > > > > > be> > > > > > > > done owing to its other hazardous side effects.> > > > > > > >> > > > > > > >> > > > > > > >> > > > > > > > Regards,> > > > > > > >> > > > > > > > Dr Deepali> > > > > > > >> > > > > > > > GMC> > > > > > > >> > > > > > > > Nagpur> > > > > > >> > > > > > === message truncated ===> > > > > >> > > > > >> > > > > >> > > > > > Chat on a cool, new interface. No download required. Go to> > > > http://in.messenger./webmessengerpromo.php> > > > > >> > > > >> > > > >> > > > >> > > > >> > > > >> > > > >> > > > > ---------------------------------> > > > > Share files, take polls, and discuss your passions - all > under> > > one> > > > roof. Click here.> > > > >> > > >> > >> >>

[Guest guest]

Hello,

In continuation with the previous post here is the elaborated view of hurdles in paediatric pharmacovigilanceà

The lack of reliable data in paediatric populations is associated with particular problems in p'vigilance including:

o Limited available safety data due to lack of clinical trials in the paediatric population;

o lack of pharmacokinetics data or dose-finding studies leads to:

§ Under-dosing may result in lack of benefit or development of resistance

§ Over-dosing may result in an increase of Type A reactions

o Incorrect dosing, use of products of less controlled quality or inappropriately high local concentrations leading to local adverse reactions due to lack of age-appropriate formulations

o Safety data in the paediatric population cannot necessarily be extrapolated from data in adults because

§ The pharmacokinetics and pharmacodynamics of a compound may be different in the paediatric population making it particularly vulnerable to ADRs or have different drug interaction profiles;

§ The paediatric population may be more susceptible to ADRs from specific excipients;

§ Different ADRs may be relevant for different paediatric age groups and specific pharmacovigilance plans, strategies and activities should be tailored accordingly. In utero exposure may represent an additional risk factor and premature babies need extra-vigilent view;

§ Maturation, growth and development in the paediatric population may be susceptible to drug-induced growth and developmental disorders, as well as to delayed ADRs not seen in adults requiring long term follow-up data to detect such effects;

§ Drug-induced "programming" may occur i.e. permanent effects may result from a drug exposure at a sensitive point in development (`critical window'), this is a particular consideration in foetal or neonatal life;

§ Life-long treatments for chronic diseases may expose the patient to increased risks of developing an ADR.

o The problems are accentuated when the drugs involved are not authorised for paediatric use:

§ Unlicensed medicines or medicines used `off-label' may have inadequate product information to support safe paediatric use;

§ Underreporting of adverse reactions may occur in relation to unlicensed or `off-label' use due to legal and liability concerns.

o Children may be unable to communicate adverse reactions clearly to their carers/ health care professionals or may not be aware of the adverse reactions as such.

Also as disease status, socioeconomic status, social values changes region wise, state wise, nation wise and last but not of least importance child wise, it is essential to develop extensive p'vigilance data.

How this can be achieved?

Regards,

Dr Smita,

GMC, Nagpur.> > > > > > > > >> > > > > > > > >> > > > > > > > > Hello Smita and Netrumians,> > > > > > > > >> > > > > > > > >> > > > > > > > >> > > > > > > > > First of all congratulations for getting> > > > > > > > opportunity to moderate> > > > > > > > once> > > > > > > > > again.> > > > > > > > >> > > > > > > > > A sick child is the source of great anxiety to> > > > > > > > both doctors and> > > > > > > > carers,> > > > > > > > > can be a huge diagnostic challenge.> > > > > > > > >> > > > > > > > > Indian markets are flooded with. thousands of> > > > > > > > formulations of> > > > > > > > vitamins,> > > > > > > > > tonics and multi-drug combinations that are unique> > > > > > > > to the Indian> > > > > > > > market> > > > > > > > > are manufactured and marketed here. A visit to the> > > > > > > > pediatrician> > > > > > > > has come> > > > > > > > > to necessarily mean a prescription comprising of a> > > > > > > > shot gun> > > > > > > > combination> > > > > > > > > of antibiotics & #8211; one and more, an anti> > > > > > > pyretic or> > > > > > > > frequently an> > > > > > > > > unnecessary combination of two, a multivitamin> > > > > > > > tonic and a> > > > > > > > combination> > > > > > > > > cough syrup. Intravenous rehydration and> > > > > > > > parenteral medication are> > > > > > > > used> > > > > > > > > far more frequently than rationally warranted.> > > > > > > > Widespread> > > > > > > > experience> > > > > > > > > clearly shows that the vast majority of doctors'> > > > > > > > prescriptions for> > > > > > > > > children are quite irrational.> > > > > > > > >> > > > > > > > > Analyzing some of the commonest prescribed groups> > > > > > > > of drugsà> > > > > > > > >> > > > > > > > > Tonics And Cough Syrupsà> > > > > > > > >> > > > > > > > > According to Health Action International "More> > > > > > > > than four out of> > > > > > > > > every five vitamin preparations cannot be> > > > > > > > recommended; nearly> > > > > > > > three out> > > > > > > > > of every five is indicated for unproven> > > > > > > > indications; more than two> > > > > > > > out> > > > > > > > > of every five contain non-essential or ineffective> > > > > > > > ingredients;> > > > > > > > more> > > > > > > > > than one out of every two is irrationally> > > > > > > > formulated; and nearly> > > > > > > > one out> > > > > > > > > of every two contains excessive dosage."> > > > > > > > >> > > > > > > > > Over 80 per cent of cough and cold remedies on the> > > > > > > > market are> > > > > > > > > irrational, most with ineffective and some with> > > > > > > > dangerous> > > > > > > > ingredients.> > > > > > > > >> > > > > > > > > Vaccinesà> > > > > > > > >> > > > > > > > > There is growing trend towards prescribing> > > > > > > > optional vaccines and> > > > > > > > > vaccines like> > > > > > > > >> > > > > > > > > anti pneumococcal vaccine and influenza vaccine> > > > > > > > are being used> > > > > > > > routinely> > > > > > > > > by some, if not many doctors though this has no> > > > > > > > current> > > > > > > > justification> > > > > > > > > Vaccinations have become the major source of> > > > > > > > bread and butter of> > > > > > > > the> > > > > > > > > pediatrician.> > > > > > > > >> > > > > > > > > Analgesicsà> > > > > > > > >> > > > > > > > > The medical community's response to drugs like> > > > > > > > nimuselide, a drug> > > > > > > > > aggressively promoted in India for bringing down> > > > > > > > fever in> > > > > > > > children, is> > > > > > > > > also an eye opener. The justice is still out in> > > > > > > > India as to its> > > > > > > > safety> > > > > > > > > in children, with many professional organisations> > > > > > > > declaring it> > > > > > > > safe and> > > > > > > > > others claiming to have seen children die as a> > > > > > > > result of liver> > > > > > > > failure> > > > > > > > > from its use. so why to take risk when there are> > > > > > > > excellent time> > > > > > > > tested> > > > > > > > > safe analgesia is available for children. other> > > > > > > > countries, issued a> > > > > > > > > precautionary advice on the marketing of the drug> > > > > > > > following some> > > > > > > > serious> > > > > > > > > complications of the liver, especially in> > > > > > > > children. Owing to the> > > > > > > > death> > > > > > > > > of a patient due to liver failure and following> > > > > > > > reports of other> > > > > > > > adverse> > > > > > > > > drug reaction, banned in many countries It is> > > > > > > > interesting to note> > > > > > > > that.> > > > > > > > > Bangladesh was the last country to ban the drug.> > > > > > > > However,> > > > > > > > paediatricians> > > > > > > > > in India continue blissfully to prescribe the drug> > > > > > > > and drug> > > > > > > > companies> > > > > > > > > continue to prevail upon them and make it> > > > > > > > lucrative for the> > > > > > > > practice to> > > > > > > > > continue.> > > > > > > > >> > > > > > > > > Sedativesà> > > > > > > > >> > > > > > > > > Prescribing any kind of sedative just because to> > > > > > > > diminish crying in> > > > > > > > > infants in highly objectionable. Many pediatrician> > > > > > > > giving H1> > > > > > > > > antihistaminic hydroxyzine only to calm children,> > > > > > > > which should not> > > > > > > > be> > > > > > > > > done owing to its other hazardous side effects.> > > > > > > > >> > > > > > > > >> > > > > > > > >> > > > > > > > > Regards,> > > > > > > > >> > > > > > > > > Dr Deepali> > > > > > > > >> > > > > > > > > GMC> > > > > > > > >> > > > > > > > > Nagpur> > > > > > > >> > > > > > > === message truncated ===> > > > > > >> > > > > > >> > > > > > >> > > > > > > Chat on a cool, new interface. No download required. Go to> > > > > http://in.messenger./webmessengerpromo.php> > > > > > >> > > > > >> > > > > >> > > > > >> > > > > >> > > > > >> > > > > >> > > > > > ---------------------------------> > > > > > Share files, take polls, and discuss your passions - all> > under> > > > one> > > > > roof. Click here.> > > > > >> > > > >> > > >> > >> >>

[Guest guest]

could a group of netrum members compile the list and adverse reaction of drugs which than can be circulated to various groups of doctors like DMA

rgds

anil varshney

IMMUNIZE EVERY CHILD FOR HEALTHY FUTURE, PREVENT AIDS ,-PRACTICE SAFE SEX ,EAT HEALTHY FOODS SLEEP WELL , EXERCISE DAILY , MEDITATE FOR HEALTHY LIVING

Re: Safe drugs for children (clinical trials)

Hello,

In continuation with the previous post here is the elaborated view of hurdles in paediatric pharmacovigilanceà

The lack of reliable data in paediatric populations is associated with particular problems in p'vigilance including:

o Limited available safety data due to lack of clinical trials in the paediatric population;

o lack of pharmacokinetics data or dose-finding studies leads to:

§ Under-dosing may result in lack of benefit or development of resistance

§ Over-dosing may result in an increase of Type A reactions

o Incorrect dosing, use of products of less controlled quality or inappropriately high local concentrations leading to local adverse reactions due to lack of age-appropriate formulations

o Safety data in the paediatric population cannot necessarily be extrapolated from data in adults because

§ The pharmacokinetics and pharmacodynamics of a compound may be different in the paediatric population making it particularly vulnerable to ADRs or have different drug interaction profiles;

§ The paediatric population may be more susceptible to ADRs from specific excipients;

§ Different ADRs may be relevant for different paediatric age groups and specific pharmacovigilance plans, strategies and activities should be tailored accordingly. In utero exposure may represent an additional risk factor and premature babies need extra-vigilent view;

§ Maturation, growth and development in the paediatric population may be susceptible to drug-induced growth and developmental disorders, as well as to delayed ADRs not seen in adults requiring long term follow-up data to detect such effects;

§ Drug-induced "programming" may occur i.e. permanent effects may result from a drug exposure at a sensitive point in development (`critical window'), this is a particular consideration in foetal or neonatal life;

§ Life-long treatments for chronic diseases may expose the patient to increased risks of developing an ADR.

o The problems are accentuated when the drugs involved are not authorised for paediatric use:

§ Unlicensed medicines or medicines used `off-label' may have inadequate product information to support safe paediatric use;

§ Underreporting of adverse reactions may occur in relation to unlicensed or `off-label' use due to legal and liability concerns.

o Children may be unable to communicate adverse reactions clearly to their carers/ health care professionals or may not be aware of the adverse reactions as such.

Also as disease status, socioeconomic status, social values changes region wise, state wise, nation wise and last but not of least importance child wise, it is essential to develop extensive p'vigilance data.

How this can be achieved?

Regards,

Dr Smita,

GMC, Nagpur .> > > > > > > > >> > > > > > > > >> > > > > > > > > Hello Smita and Netrumians,> > > > > > > > >> > > > > > > > >> > >

> > > > > >> > > > > > > > > First of all congratulations for getting> > > > > > > > opportunity to moderate> > > > > > > > once> > > > > > > > > again.> > > > > > > > >> > > > > > > > > A sick child is the source of great anxiety to> > > > > > > > both doctors and> > > > > > > > carers,> > > > > > > > > can be a huge diagnostic challenge.> > > > > > > > >> > > > > > > > > Indian markets are flooded with. thousands of> > > > > > > > formulations of> > > > > > > > vitamins,> > > > > > > > > tonics and multi-drug combinations

that are unique> > > > > > > > to the Indian> > > > > > > > market> > > > > > > > > are manufactured and marketed here. A visit to the> > > > > > > > pediatrician> > > > > > > > has come> > > > > > > > > to necessarily mean a prescription comprising of a> > > > > > > > shot gun> > > > > > > > combination> > > > > > > > > of antibiotics & #8211; one and more, an anti> > > > > > > pyretic or> > > > > > > > frequently an> > > > > > > > > unnecessary combination of two, a multivitamin> > > > > > > > tonic and a> > > > > > > > combination> > > >

> > > > > cough syrup. Intravenous rehydration and> > > > > > > > parenteral medication are> > > > > > > > used> > > > > > > > > far more frequently than rationally warranted.> > > > > > > > Widespread> > > > > > > > experience> > > > > > > > > clearly shows that the vast majority of doctors'> > > > > > > > prescriptions for> > > > > > > > > children are quite irrational.> > > > > > > > >> > > > > > > > > Analyzing some of the commonest prescribed groups> > > > > > > > of drugsà> > > > > > > > >> > > > > > > > > Tonics And Cough Syrupsà> > > >

> > > > >> > > > > > > > > According to Health Action International "More> > > > > > > > than four out of> > > > > > > > > every five vitamin preparations cannot be> > > > > > > > recommended; nearly> > > > > > > > three out> > > > > > > > > of every five is indicated for unproven> > > > > > > > indications; more than two> > > > > > > > out> > > > > > > > > of every five contain non-essential or ineffective> > > > > > > > ingredients;> > > > > > > > more> > > > > > > > > than one out of every two is irrationally> > > > > > > > formulated; and nearly> > >

> > > > > one out> > > > > > > > > of every two contains excessive dosage."> > > > > > > > >> > > > > > > > > Over 80 per cent of cough and cold remedies on the> > > > > > > > market are> > > > > > > > > irrational, most with ineffective and some with> > > > > > > > dangerous> > > > > > > > ingredients.> > > > > > > > >> > > > > > > > > Vaccinesà> > > > > > > > >> > > > > > > > > There is growing trend towards prescribing> > > > > > > > optional vaccines and> > > > > > > > > vaccines like> > > > > > > > >> > >

> > > > > > anti pneumococcal vaccine and influenza vaccine> > > > > > > > are being used> > > > > > > > routinely> > > > > > > > > by some, if not many doctors though this has no> > > > > > > > current> > > > > > > > justification> > > > > > > > > Vaccinations have become the major source of> > > > > > > > bread and butter of> > > > > > > > the> > > > > > > > > pediatrician.> > > > > > > > >> > > > > > > > > Analgesicsà> > > > > > > > >> > > > > > > > > The medical community's response to drugs like> > > > > > > > nimuselide, a

drug> > > > > > > > > aggressively promoted in India for bringing down> > > > > > > > fever in> > > > > > > > children, is> > > > > > > > > also an eye opener. The justice is still out in> > > > > > > > India as to its> > > > > > > > safety> > > > > > > > > in children, with many professional organisations> > > > > > > > declaring it> > > > > > > > safe and> > > > > > > > > others claiming to have seen children die as a> > > > > > > > result of liver> > > > > > > > failure> > > > > > > > > from its use. so why to take risk when there are> > > > > > > >

excellent time> > > > > > > > tested> > > > > > > > > safe analgesia is available for children. other> > > > > > > > countries, issued a> > > > > > > > > precautionary advice on the marketing of the drug> > > > > > > > following some> > > > > > > > serious> > > > > > > > > complications of the liver, especially in> > > > > > > > children. Owing to the> > > > > > > > death> > > > > > > > > of a patient due to liver failure and following> > > > > > > > reports of other> > > > > > > > adverse> > > > > > > > > drug reaction, banned in many countries It is> > > > >

> > > interesting to note> > > > > > > > that.> > > > > > > > > Bangladesh was the last country to ban the drug.> > > > > > > > However,> > > > > > > > paediatricians> > > > > > > > > in India continue blissfully to prescribe the drug> > > > > > > > and drug> > > > > > > > companies> > > > > > > > > continue to prevail upon them and make it> > > > > > > > lucrative for the> > > > > > > > practice to> > > > > > > > > continue.> > > > > > > > >> > > > > > > > > Sedativesà> > > > > > > > >> > > > > > > > >

Prescribing any kind of sedative just because to> > > > > > > > diminish crying in> > > > > > > > > infants in highly objectionable. Many pediatrician> > > > > > > > giving H1> > > > > > > > > antihistaminic hydroxyzine only to calm children,> > > > > > > > which should not> > > > > > > > be> > > > > > > > > done owing to its other hazardous side effects.> > > > > > > > >> > > > > > > > >> > > > > > > > >> > > > > > > > > Regards,> > > > > > > > >> > > > > > > > > Dr Deepali> > > > > > > > >> > > > > > > > >

GMC> > > > > > > > >> > > > > > > > > Nagpur> > > > > > > >> > > > > > > === message truncated ===> > > > > > >> > > > > > >> > > > > > >> > > > > > > Chat on a cool, new interface. No download required. Go to> > > > > http://in.messenger ./ webmessengerprom o.php> > > > > > >> > > > > >> > > > > >> > > > > >> > > > > >> > > > > >> > > > > >> > > > > > ------------ --------- --------- ---> > > > > > Share files, take polls, and discuss your passions - all> > under> > > > one> > >

> > roof. Click here.> > > > > >> > > > >> > > >> > >> >>

Save all your chat conversations. Find them online.

[Guest guest]

Dear Netrum members,

Please see below:

Regards

Ramagopal

-------------

Glaxo's Asthma Drugs May Harm Children, U.S. FDA Staff Says

By Fay Cortez and Rapaport

Nov. 23 (Bloomberg) -- GlaxoKline Plc's asthma drugs Serevent and Advair, the company's biggest-selling medications, may have rare and deadly side effects for children, safety officials at the U.S. Food and Drug Administration said.

Nine patients under age 16 were harmed, including five who died, while taking Serevent in the 13 months after it was approved in the U.S. for children in 2006, a safety review found. An advisory panel of pediatricians is slated to discuss side effects from Serevent and other medications on Nov. 27.

The FDA strengthened the warning labels for Serevent, Advair and Novartis AG's Foradil almost two years ago, limiting use to patients who don't benefit from other drugs. A study found patients using Serevent had a fourfold increase in asthma- related deaths, while others showed it and Foradil increased asthma exacerbations and hospitalizations in adults and children, according to the FDA staff memo Oct. 24, 2007.

``There is no available pediatric data to indicate that the increased risk of asthma death and life-threatening exacerbations observed in adults does not also apply to children,'' the FDA staff members wrote in a report posted on its Web site today. While the review didn't identify any adverse reactions unique to children, Serevent may have more risks than benefits for the youngest users, they said.

Glaxo officials weren't immediately available to comment.

The drugs are used long-term to relax the airway, control symptoms and prevent exacerbations of asthma. Almost one in 10 Americans will be diagnosed with asthma at some time, according to the National Institutes of Health. About 21 million adults and 9 million children in the U.S. currently have the condition.

Global Revenue

Global revenue for Serevent and Advair rose 12 percent to $6.13 billion last year, making the medicines the second-best- selling in the world behind Pfizer Inc.'s cholesterol drug Lipitor. Advair is a combination of the salmeterol, the chemical in Serevent, and a steroid.

Asthma is a chronic respiratory disease that causes inflammation and narrowing of airways in the lungs. Asthma attacks can be caused by changes in the weather, allergies, exercise, smoking or exposure to toxic air. Attacks can cause shortness of breath, cough, chest pain and other symptoms.

The FDA staff members said a study looking at the drugs' safety may be warranted, thought it would be difficult to enroll enough children. A more ``formal'' analysis of their risks and benefits in treating asthma in children is needed, they said.

To contact the reporter on this story: Fay Cortez in Minneapolis at mcortez@...

Last Updated: November 23, 2007 17:56 EST

[Guest guest]

Dear colleagues,

Another interesting news item regarding our latest discussion topic just out today in telegraph.co.uk

Regards

Ramagopal

------

Hyperactivity prescriptions triple in seven yearsBy Graeme Paton

Last Updated: 1:43am GMT 26/11/2007

The use of powerful mind-altering drugs to treat supposedly hyperactive or badly behaved children has tripled in just seven years, despite fears over harmful side-effects.

Figures show that GPs wrote nearly 406,000 prescriptions for such drugs last year, compared with 135,000 in 1999. Last night, politicians and children's groups branded the rise "astonishing".

Laws, the Liberal Democrat children's spokesman, said: "We need a fundamental review of whether we are right to be pouring chemicals into our children in this way. Perhaps we should instead be looking at issues such as food, sleeping patterns, family upheaval, and general environment."

Mr Laws, who obtained the figures in a Parliamentary question, said some families may be pressuring GPs to prescribe drugs to allow them to claim child disability allowances.

Parents who have a child diagnosed with Attention Deficit Hyperactivity Disorder (ADHD) are entitled to benefits of up to £10,000 a year. According to the latest figures, more than £17 million was spent last year on drugs to treat ADHD.

Prescriptions for the anti-ADHD drug Ritalin - said to be linked to depression, drowsiness, epilepsy and high blood pressure - slumped from 168,300 in 2001 to just 21,681 last year. However, other drugs using the same ingredient - methylphenidate hydrochloride - soared over the same period.

Prescriptions of Concerta rose from 43,100 in 2002 to 226,442 last year, while Equasym prescriptions rose from 4,400 in 2000 to 57,475.

A spokesman for the Swiss firm Novartis, which makes Ritalin, said "it has been used safely and effectively in the treatment of ADHD over more than 50 years and is one of the most studied drugs prescribed for the disorder".

"Novartis supports only the appropriate use of Ritalin, as indicated and prescribed by qualified, licensed healthcare professionals."

..

[Guest guest]

Hello Sir,

It is nice to have such a recent news input from you. When had a look for the name mentioned in the post it was found that Concerta and Equasym are extended/modified release formulations of methylphenidate (MPH). Also as said in post it's just different brand of same medicine i.e. MPH have different sell profile.

This may be because of different ADRs of the brands of same basic medicine which in turn may be contributed by formulations, excipients of respective brand.

Increased exposure of children to the medicines might be result of pseudo raised awareness of parents regarding health. Many times it is seen that just for the sake children are supplied with unnecessary tonics, vaccines. Due education of parents regarding these points is essential.

Here is the paragraph from WHO publication which gives information regarding MPH.

Medicines used for treating attention-deficit hyperactivity disorder

Attention deficit hyperactivity disorder (ADHD) is being increasingly diagnosed and treated in children. A recommended medicine, methylphenidate (MPH), is being increasingly used to treat this condition.

Its side-effects increase linearly with dose, and include appetite suppression, insomnia, tachycardia, nervousness and headache (1); fixed medicine eruption induced by MPH is a rare adverse effect (2); and a small minority of ADHD children on MPH therapy is also at risk for serious growth decrement (3). In addition, preliminary data suggest a significant nocturnal dipping of blood pressure (BP) during sleeping hours and greater elevations in BP during waking hours (4).

Paediatricians should, therefore, closely monitor the dose-related side-effects and aim for the lowest effective dose. They should also monitor heart rate, BP and growth in children on MPH therapy.

Pemoline is another medicine used to treat ADHD. There have been reports of serious hepatotoxicity (hepatic enzyme abnormalities, jaundice and even death) ascribed to its use. Limitations in post-marketing surveillance and public reporting in the United States of America, particularly in the 1980s, largely accounted for delays in initiating an appropriate response to pemoline hepatotoxicity (5).

Regards,

Dr Smita,

GMC, Nagpur. >> Dear colleagues,> > Another interesting news item regarding our latest discussion topic just out today in telegraph.co.uk> > Regards > > Ramagopal> > ------> > > > > > > Hyperactivity prescriptions triple in seven years> > > By Graeme Paton> > Last Updated: 1:43am GMT 26/11/2007> > > > The use of powerful mind-altering drugs to treat supposedly hyperactive or badly behaved children has tripled in just seven years, despite fears over harmful side-effects.> > Figures show that GPs wrote nearly 406,000 prescriptions for such drugs last year, compared with 135,000 in 1999. Last night, politicians and children's groups branded the rise "astonishing".> > Laws, the Liberal Democrat children's spokesman, said: "We need a fundamental review of whether we are right to be pouring chemicals into our children in this way. Perhaps we should instead be looking at issues such as food, sleeping patterns, family upheaval, and general environment."> > Mr Laws, who obtained the figures in a Parliamentary question, said some families may be pressuring GPs to prescribe drugs to allow them to claim child disability allowances.> > Parents who have a child diagnosed with Attention Deficit Hyperactivity Disorder (ADHD) are entitled to benefits of up to £10,000 a year. According to the latest figures, more than £17 million was spent last year on drugs to treat ADHD.> > Prescriptions for the anti-ADHD drug Ritalin - said to be linked to depression, drowsiness, epilepsy and high blood pressure - slumped from 168,300 in 2001 to just 21,681 last year. However, other drugs using the same ingredient - methylphenidate hydrochloride - soared over the same period.> > Prescriptions of Concerta rose from 43,100 in 2002 to 226,442 last year, while Equasym prescriptions rose from 4,400 in 2000 to 57,475.> > A spokesman for the Swiss firm Novartis, which makes Ritalin, said "it has been used safely and effectively in the treatment of ADHD over more than 50 years and is one of the most studied drugs prescribed for the disorder".> > "Novartis supports only the appropriate use of Ritalin, as indicated and prescribed by qualified, licensed healthcare professionals."> > .> <http://geo./serv?s=97359714/grpId=17458078/grpspId=1705118787/msgId=2757/stime=1196091676/nc1=4718982/nc2=5008809/nc3=4507179>>

[Guest guest]

Hello Sir,

NetRUMians will definitely be happy to have such updated news

provided by you. I seek opinions from all regarding this, as news

can be interpreted in different way.

Regards,

Dr Smita,

GMC, Nagpur.

>

> Dear Netrum members,

>

> Please see below:

>

> Regards

>

> Ramagopal

>

> -------------

>

> Glaxo's Asthma Drugs May Harm Children, U.S. FDA Staff Says

>

>

> By Fay Cortez and Rapaport

>

> Nov. 23 (Bloomberg) -- GlaxoKline Plc's asthma drugs Serevent

and Advair, the company's biggest-selling medications, may have rare

and deadly side effects for children, safety officials at the U.S.

Food and Drug Administration said.

>

> Nine patients under age 16 were harmed, including five who died,

while taking Serevent in the 13 months after it was approved in the

U.S. for children in 2006, a safety review found. An advisory panel

of pediatricians is slated to discuss side effects from Serevent and

other medications on Nov. 27.

>

> The FDA strengthened the warning labels for Serevent, Advair and

Novartis AG's Foradil almost two years ago, limiting use to patients

who don't benefit from other drugs. A study found patients using

Serevent had a fourfold increase in asthma- related deaths, while

others showed it and Foradil increased asthma exacerbations and

hospitalizations in adults and children, according to the FDA staff

memo Oct. 24, 2007.

>

> ``There is no available pediatric data to indicate that the

increased risk of asthma death and life-threatening exacerbations

observed in adults does not also apply to children,'' the FDA staff

members wrote in a report posted on its Web site today. While the

review didn't identify any adverse reactions unique to children,

Serevent may have more risks than benefits for the youngest users,

they said.

>

> Glaxo officials weren't immediately available to comment.

>

> The drugs are used long-term to relax the airway, control symptoms

and prevent exacerbations of asthma. Almost one in 10 Americans will

be diagnosed with asthma at some time, according to the National

Institutes of Health. About 21 million adults and 9 million children

in the U.S. currently have the condition.

>

> Global Revenue

>

> Global revenue for Serevent and Advair rose 12 percent to $6.13

billion last year, making the medicines the second-best- selling in

the world behind Pfizer Inc.'s cholesterol drug Lipitor. Advair is a

combination of the salmeterol, the chemical in Serevent, and a

steroid.

>

> Asthma is a chronic respiratory disease that causes inflammation

and narrowing of airways in the lungs. Asthma attacks can be caused

by changes in the weather, allergies, exercise, smoking or exposure

to toxic air. Attacks can cause shortness of breath, cough, chest

pain and other symptoms.

>

> The FDA staff members said a study looking at the drugs' safety

may be warranted, thought it would be difficult to enroll enough

children. A more ``formal'' analysis of their risks and benefits in

treating asthma in children is needed, they said.

>

> To contact the reporter on this story: Fay Cortez in

Minneapolis at mcortez@...

>

> Last Updated: November 23, 2007 17:56 EST

>

> <http://geo./serv?

s=97359714/grpId=17458078/grpspId=1705118787/msgId=2726/stime=1195888

715/nc1=4836034/nc2=5008807/nc3=4507179>

>

[Guest guest]

Dear ramagopal

That is a nice update.

Vijay

>

> Dear colleagues,

>

> Another interesting news item regarding our latest discussion

topic just out today in telegraph.co.uk

>

> Regards

>

> Ramagopal

>

> ------

>

>

>

>

>

>

> Hyperactivity prescriptions triple in seven years

>

>

> By Graeme Paton

>

> Last Updated: 1:43am GMT 26/11/2007

>

>

>

> The use of powerful mind-altering drugs to treat supposedly

hyperactive or badly behaved children has tripled in just seven

years, despite fears over harmful side-effects.

>

> Figures show that GPs wrote nearly 406,000 prescriptions for such

drugs last year, compared with 135,000 in 1999. Last night,

politicians and children's groups branded the rise " astonishing " .

>

> Laws, the Liberal Democrat children's spokesman, said: " We

need a fundamental review of whether we are right to be pouring

chemicals into our children in this way. Perhaps we should instead

be looking at issues such as food, sleeping patterns, family

upheaval, and general environment. "

>

> Mr Laws, who obtained the figures in a Parliamentary question,

said some families may be pressuring GPs to prescribe drugs to allow

them to claim child disability allowances.

>

> Parents who have a child diagnosed with Attention Deficit

Hyperactivity Disorder (ADHD) are entitled to benefits of up to

£10,000 a year. According to the latest figures, more than £17

million was spent last year on drugs to treat ADHD.

>

> Prescriptions for the anti-ADHD drug Ritalin - said to be linked

to depression, drowsiness, epilepsy and high blood pressure -

slumped from 168,300 in 2001 to just 21,681 last year. However,

other drugs using the same ingredient - methylphenidate

hydrochloride - soared over the same period.

>

> Prescriptions of Concerta rose from 43,100 in 2002 to 226,442 last

year, while Equasym prescriptions rose from 4,400 in 2000 to 57,475.

>

> A spokesman for the Swiss firm Novartis, which makes Ritalin,

said " it has been used safely and effectively in the treatment of

ADHD over more than 50 years and is one of the most studied drugs

prescribed for the disorder " .

>

> " Novartis supports only the appropriate use of Ritalin, as

indicated and prescribed by qualified, licensed healthcare

professionals. "

>

> .

> <http://geo./serv?

s=97359714/grpId=17458078/grpspId=1705118787/msgId=2757/stime=1196091

676/nc1=4718982/nc2=5008809/nc3=4507179>

>

[Guest guest]

Hi all

Information about medicines to children helps in many ways. It not only promotes safety but makes them responsible consumers as adults in future. Problems associated with non compliance and self medication can be minimised if started early. The moot point is how and how early?

These guidelines appeared quite some time ago but are far from being implemented in our country.

Copied from USP.org for fair use...Ten Guiding Principles for Teaching Children and Adolescents About Medicines

A Position Statement of the United States Pharmacopeia

These Principles are intended to encourage activities that will help children, through adolescence, become active participants in the process of using

medicines* to the best of their abilities. Recognizing that children of the same age vary in development, experience, and capabilities, these Principles do not specify children's ages.

Children, as users of medicines, have a right to appropriate information about their medicines that reflects the child's health status, capabilities, and culture. Children want to know. Health care providers and health educators should communicate directly with children about their medicines. Children's interest in medicines should be encouraged, and they should be taught how to ask questions of health care providers, parents, and other care givers about medicines and other therapies. Children learn by example. The actions of parents and other care givers should show children appropriate use of medicines. Children, their parents, and their health care providers should negotiate the gradual transfer of responsibility for medicine use in ways that respect parental responsibilities and the health status and capabilities of the child. Children's medicine education should take into account what children want to know about medicines, as well as what health professionals think children should know. Children should receive basic information about medicines and their proper use as a part of school health education. Children's medicine education should include information about the general use and misuse of medicines, as well as about the specific medicines the child is using. Children have a right to information that will enable them to avoid poisoning through the misuse of medicines. Children asked to participate in clinical trials (after parents' consent) have a right to receive appropriate information to promote their understanding before assent and participation.

* Medicines include all types: prescription medicines, non-prescription medicines, herbal remedies, and nutritional supplements such as vitamins and minerals.

More information on this on this link too..

http://www.usp.org/audiences/consumers/children/Chetna Desai

On 27/11/2007, Vijay <drvijaythawani@...> wrote:

Dear ramagopalThat is a nice update.Vijay>

> Dear colleagues,> > Another interesting news item regarding our latest discussion topic just out today in

telegraph.co.uk> > Regards > > Ramagopal> > ------> > > > > > > Hyperactivity prescriptions triple in seven years>

> > By Graeme Paton> > Last Updated: 1:43am GMT 26/11/2007> > > > The use of powerful mind-altering drugs to treat supposedly hyperactive or badly behaved children has tripled in just seven years, despite fears over harmful side-effects.> > Figures show that GPs wrote nearly 406,000 prescriptions for such drugs last year, compared with 135,000 in 1999. Last night, politicians and children's groups branded the rise " astonishing " .

> > Laws, the Liberal Democrat children's spokesman, said: " We need a fundamental review of whether we are right to be pouring chemicals into our children in this way. Perhaps we should instead be looking at issues such as food, sleeping patterns, family upheaval, and general environment. " > > Mr Laws, who obtained the figures in a Parliamentary question, said some families may be pressuring GPs to prescribe drugs to allow them to claim child disability allowances.> > Parents who have a child diagnosed with Attention Deficit Hyperactivity Disorder (ADHD) are entitled to benefits of up to £10,000 a year. According to the latest figures, more than £17 million was spent last year on drugs to treat ADHD.> > Prescriptions for the anti-ADHD drug Ritalin - said to be linked to depression, drowsiness, epilepsy and high blood pressure - slumped from 168,300 in 2001 to just 21,681 last year. However, other drugs using the same ingredient - methylphenidate hydrochloride - soared over the same period.> > Prescriptions of Concerta rose from 43,100 in 2002 to 226,442 last year, while Equasym prescriptions rose from 4,400 in 2000 to 57,475.

> > A spokesman for the Swiss firm Novartis, which makes Ritalin, said " it has been used safely and effectively in the treatment of ADHD over more than 50 years and is one of the most studied drugs prescribed for the disorder " .> > " Novartis supports only the appropriate use of Ritalin, as indicated and prescribed by qualified, licensed healthcare professionals. " > > .

> <http://geo./serv?s=97359714/grpId=17458078/grpspId=1705118787/msgId=2757/stime=1196091

676/nc1=4718982/nc2=5008809/nc3=4507179>>

-- Dr Chetna Desai

[Guest guest]

Hello Madam,

The information provided by you from usp.org is a ten step ladder leading the child to a "responsible" patient, care taker in future, on and all a vigilant citizen.

The information from the link http://www.usp.org/pdf/EN/consumers/guide.pdf which is given below needs to be given attention.

MAY HAVE THESE MEDICINES IF CHILD NEEDS THEM

Ø For allergies, a kind of antihistamine (chlorpheniramine, brompheniramine, diphenhydramine, triprolidine, carbinoxamine, hydroxyzine)

Ø For itching and bites: calamine lotion and 1% hydrocortisone ointment

Ø For the common cold: nose drops containing a decongestant (phenylephrine, ephedrine, or oxymetazoline)

Ø For severe coughs: a cough syrup - some contain a cough suppressant (dextromethorphan - known as DM) and some also contain an expectorant (guaifenesin). A vaporizer works best.

Ø For repeated ear infections: a decongestant (pseudoephedrine, ephedrine)

Ø For diarrhea: oral rehydration therapy (ORT); ORT is a mixture of sugar, salt, and water that can be made at home. Dissolve 4 level teaspoonfuls of sugar and 1/2 level teaspoon of salt in 1 quart (4 cups) of clean water (boil if not sure).

As discussed earlier in the forum use of cough syrups, dextromethorphan, antihistaminics in children is questionable.

Also use of decongestant nasal drops should be followed after the proper instructions regarding its side effects such as atrophic rhinitis, anosmia which might develop after its regular use.

Regards,

Dr Smita,

GMC, Nagpur.

> > >> > > Dear colleagues,> > >> > > Another interesting news item regarding our latest discussion> > topic just out today in telegraph.co.uk> > >> > > Regards> > >> > > Ramagopal> > >> > > ------> > >> > >> > >> > >> > >> > >> > > Hyperactivity prescriptions triple in seven years> > >> > >> > > By Graeme Paton> > >> > > Last Updated: 1:43am GMT 26/11/2007> > >> > >> > >> > > The use of powerful mind-altering drugs to treat supposedly> > hyperactive or badly behaved children has tripled in just seven> > years, despite fears over harmful side-effects.> > >> > > Figures show that GPs wrote nearly 406,000 prescriptions for such> > drugs last year, compared with 135,000 in 1999. Last night,> > politicians and children's groups branded the rise "astonishing".> > >> > > Laws, the Liberal Democrat children's spokesman, said: "We> > need a fundamental review of whether we are right to be pouring> > chemicals into our children in this way. Perhaps we should instead> > be looking at issues such as food, sleeping patterns, family> > upheaval, and general environment."> > >> > > Mr Laws, who obtained the figures in a Parliamentary question,> > said some families may be pressuring GPs to prescribe drugs to allow> > them to claim child disability allowances.> > >> > > Parents who have a child diagnosed with Attention Deficit> > Hyperactivity Disorder (ADHD) are entitled to benefits of up to> > £10,000 a year. According to the latest figures, more than £17> > million was spent last year on drugs to treat ADHD.> > >> > > Prescriptions for the anti-ADHD drug Ritalin - said to be linked> > to depression, drowsiness, epilepsy and high blood pressure -> > slumped from 168,300 in 2001 to just 21,681 last year. However,> > other drugs using the same ingredient - methylphenidate> > hydrochloride - soared over the same period.> > >> > > Prescriptions of Concerta rose from 43,100 in 2002 to 226,442 last> > year, while Equasym prescriptions rose from 4,400 in 2000 to 57,475.> > >> > > A spokesman for the Swiss firm Novartis, which makes Ritalin,> > said "it has been used safely and effectively in the treatment of> > ADHD over more than 50 years and is one of the most studied drugs> > prescribed for the disorder".> > >> > > "Novartis supports only the appropriate use of Ritalin, as> > indicated and prescribed by qualified, licensed healthcare> > professionals."> > >> > > .> > > <http://geo./serv?> > s=97359714/grpId=17458078/grpspId=1705118787/msgId=2757/stime=1196091> > 676/nc1=4718982/nc2=5008809/nc3=4507179>> > >> >> > > >> > > > -- > Dr Chetna Desai>